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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePERCLOSE PROSTAR XL 10 FRENCH PVS SYSTEM
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS006
Date Received03/13/1998
Decision Date04/06/1998
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the pvs patient guide and post-procedure (nursing) guide.
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